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A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease

2016-11-30 15:45:36 | BioPortfolio

Summary

The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease.

Description

This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in approximately 126 subjects with a confirmed diagnosis of CD for at least three months and have CD involving the ileum and/or colon. Following a screening period of up to 28 days, subjects will be randomly allocated into one of two treatment arms: either V565 or placebo using a 2:1 active:placebo ratio for a treatment period of 6 weeks.

Subjects will be treated with study drug as an add-on to any permitted stable medications already being taken for CD.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Crohn's Disease

Intervention

V565, Placebo

Status

Not yet recruiting

Source

VHsquared Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-30T15:45:36-0500

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A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.

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